SOP Guide for Pharma

Tablets: SOP for Real-Time Tablet Thickness Control – V 2.0

Auditor

Tablets: SOP for Real-Time Tablet Thickness Control – V 2.0

Standard Operating Procedure for Real-Time Tablet Thickness Control

Department Quality Control
SOP No. SOP/TAB/123/2025
Supersedes SOP/TAB/123/2022
Page No. Page 1 of 6
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

To define the procedure for real-time monitoring and control of tablet thickness during the compression process, ensuring uniformity and adherence to product specifications.

2. Scope

This SOP applies to the real-time monitoring of tablet thickness during the compression process in tablet manufacturing. It ensures that tablets are consistently within the required thickness specifications.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring real-time monitoring and control of tablet thickness during the compression process. The QA Manager is responsible for reviewing records and ensuring compliance with internal and regulatory standards.

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5. Procedure

5.1 Sample Collection

  1. During tablet compression, collect a representative sample of tablets at regular intervals, typically every 15 minutes or after producing a set number of tablets (e.g., every 100 tablets).
  2. Ensure that the sample size is sufficient for accurate measurements, usually 10 tablets per sample.

5.2 Tablet Thickness Measurement

  1. Use a calibrated tablet thickness gauge or micrometer to measure the thickness of each tablet in the sample.
  2. Ensure that the instrument is properly calibrated and zeroed before taking measurements.
  3. Record the thickness value of each tablet and calculate the average thickness of the sample.
  4. If applicable, measure the thickness at multiple points on each tablet to ensure uniformity.

5.3 Real-Time Monitoring and Adjustment

  1. Monitor tablet thickness continuously during the compression process, making adjustments as needed to ensure tablets are within the specified thickness range.
  2. If the measured tablet thickness deviates from the target thickness (typically ±10% of the target thickness), adjust the compression machine settings accordingly, such as adjusting the compression force, tablet fill weight, or machine speed.
  3. After adjusting the compression machine, re-sample and measure the tablet thickness to verify that the adjustments resulted in tablets meeting the target thickness.
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5.4 Monitoring Frequency

  1. Tablet thickness should be monitored at regular intervals throughout the compression process, typically every 15 minutes or after every 100 tablets produced.
  2. If any irregularities are observed, increase the frequency of monitoring until the issue is resolved.

5.5 Documentation

  1. Record the following information during each tablet thickness monitoring interval:
    • Sample number and time of collection
    • Individual tablet thickness values
    • Average tablet thickness
    • Deviation from target thickness and any adjustments made
  2. Document any deviations from the target thickness and corrective actions taken in the deviation report (Annexure-1).
  3. Ensure that all records are signed and dated by the responsible personnel and reviewed by QA for compliance.

5.6 Acceptance Criteria

  1. The tablet thickness should be within the specified range, typically ±10% of the target thickness.
  2. If the tablet thickness falls outside the acceptable limits, investigate the cause and take corrective actions, including potential rework or rejection of the batch.

5.7 Post-Compression Actions

  1. Once the tablet thickness is within specification, proceed with the other post-compression processes, such as coating, packaging, and storage.
  2. Ensure that any adjustments made to the compression machine are recorded and that the equipment is cleaned and calibrated as required.
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6. Abbreviations

7. Documents

  1. Batch Record (Annexure-2)
  2. Deviation Report (Annexure-1)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
15/12/2025 Batch 001 Tablet thickness deviation > 10% Adjusted compression force and re-tested John Doe

Annexure-2: Batch Record

Sample Number Tablet Thickness (mm) Average Thickness (mm) Deviation (%) Action Taken
Sample 1 4.80 4.75 ±1.2% Accepted

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated tablet thickness acceptance criteria Refined quality control processes QA Head
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